510(k) K161610
K161610 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "EXPRT Revision Hip System". The FDA issued a decision of Substantially Equivalent on November 9, 2016. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Encore Medical L.P. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2016
- Date Received
- June 10, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3310
- Review Panel
- OR
- Submission Type